RecruitingPhase 2NCT05028153
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
Sponsor
Copenhagen Studies on Asthma in Childhood
Enrollment
320 participants
Start Date
Nov 14, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this double-blind, randomized, controlled clinical trial is to investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.
Eligibility
Min Age: 12 MonthsMax Age: 71 Months
Inclusion Criteria4
- Previous episode(s) with asthma-like symptoms and / medical treatment with SABA as mono-therapy or SABA in combination with ICS and possibly LTRA.
- The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial.
- The child is between 12-71 months old.
- Fluent Danish skills with parents / guardians.
Exclusion Criteria7
- Known allergy to macrolide antibiotics.
- Known impaired liver function.
- Known renal impairment.
- Known with neurological or psychiatric diseases.
- Known with congenital or documented acquired QT interval.
- Known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
- Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)\> 50 and / or Fever: temperature\> 39 °C and / or C-reactive protein (CRP)\> 50).
Interventions
DRUGAzithromycin Oral Liquid Product
10 mg/kg for 3 consecutive days
OTHERPlacebo mixture
Placebo mixture containing no active substance
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05028153